Though they are both multiple myeloma drugs with the same mechanism of action, Sanofi’s Sarclisa has had difficulty competing with Johnson & Johnson’s powerhouse Darzalex, largely because it reached the market five years later.
But one advancement that could help Sanofi close some of the gap is its on-body delivery system for its CD38 antibody.
Tuesday, at the American Society of Clinical Oncology annual meeting in Chicago, Sanofi presented data from two trials that showed Sarclisa administered subcutaneously (SC) from an investigational on-body injector (OBI) reduced treatment time and produced similar efficacy and safety compared to intravenous (IV) infusion.
These are the first two studies to test the use of an OBI in the treatment of multiple myeloma. The company added that the trials will back regulatory submissions in the first half of this year.
“We believe the novel on-body injector represents a significant innovation that could improve and streamline the treatment process for both patients and providers,” Alyssa Johnsen, M.D., Ph.D., Sanofi’s global head of immunology and oncology development, said in a release.
In the phase 3 IRAKLIA noninferiority study for patients who had received at least one prior line of treatment, Sarclisa SC in combination with pomalidomide and dexamethasone (Pd) provided a 71.1% objective response rate (ORR) compared to 70.5% ORR for Sarclisa IV-Pd with a 12 month follow-up.
In the phase 2 IZALCO trial in multiple myeloma patients who had received at least one line of prior therapy, Sarclisa SC administered by way of a manual push or an OBI, in combination with carfilzomib and dexamethasone (Kd), delivered an 80% ORR, which validated the study’s prespecified efficacy hypothesis, Sanofi said.
In both studies, Sanofi’s SC version was consistent with the established safety profile of Sarclisa IV.
The subcutaneous formulation of Sarclisa is delivered by Enable Injections’ enFuse automated device, which gained its first FDA approval two years ago as an on-body delivery system for Apellis Pharmaceuticals’ paroxysmal nocturnal hemoglobinuria drug Empaveli.
Patient comfort is enhanced by a 30-gauge retractable needle that is smaller than some of the large-volume SC injection needles, Sanofi said.
While Sarclisa’s SC formulation has yet to be approved, J&J gained its SC nod for Darzalex Faspro in 2020, which has helped build its sales to $11.7 billion in 2024, compared to $471 million for Sarclisa. Darzalex was originally approved as a second-line treatment for multiple myeloma in 2015, while Sarclisa answered with its first nod in 2020. Darzalex gained its first-line nod in 2019, while Sarclisa answered with its first-line approval last year.
The manual injection of large-volume treatments—such as Sarclisa and Darzalex—can “present significant challenges,” Sanofi said, adding that it is a labor-intensive process for nurses, with an added risk of “strain and needlestick injuries.” When larger needles are used, it can compromise patient comfort, the company added.
Sanofi also is investigating Sarclisa SC administration by way of an OBI in newly diagnosed multiple myeloma patients.